A placebo-controlled study to assess efficacy, safety, tolerability and PK/PD of MOR106 in subjects with moderate to severe atopic dermatitis
- Conditions
- atopic dermatitisMedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-001142-10-DE
- Lead Sponsor
- Galapagos N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Subjects who meet all of the following criteria are eligible for the study:
1. Male or female between 18-65 years of age (extremes included), on the day of signing informed consent form (ICF).
2. Able and willing to give voluntary written informed consent and meet all of the inclusion criteria and none of the exclusion criteria before being enrolled in the study. The subjects must sign the informed consent form prior to any study-related procedures and agree to the schedule of assessments.
3. A body mass index (BMI) between =18 and =30 kg/m².
4. Diagnosis of chronic atopic dermatitis with at least 1 year since first diagnosis, as per the Hanifin and Rajka Criteria, fulfilling the following criteria:
a. EASI =12 at screening and =16 at baseline (Day 1 pre-dose).
b. Investigator’s Global Assessment (IGA) score =3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and at baseline.
c. Greater than or equal to 10% BSA of atopic dermatitis involvement at screening.
d. Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before baseline and throughout the study.
e. Subject is a candidate for systemic therapy and has a history of inadequate response or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors before screening visit, as per investigator’s opinion.
5. Willing to adhere to the following contraceptive restrictions:
a. Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline.
b. Female subjects of childbearing potential must use a highly effective method of contraception as described in Section 4.2.4.1.1, from 28 days prior to the first dose of study drug, during the study, and for at least 24 weeks after the last dose of study drug.
c. Non-vasectomized male subjects with a female partner of childbearing potential must agree to a highly effective form of contraception as described in Section 4.2.4.1.2, during the study, and for at least 24 weeks after last dose of study drug.
d. All male subjects must agree to use a condom from the first dose of IMP, during the study and for at least 24 weeks after the last dose of IMP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting one or more of the following criteria cannot be selected for this study:
1. Known hypersensitivity to study drug ingredients or history of any significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
2. Prior treatment with MOR106.
3. Positive serology for hepatitis B (positive hepatitis B surface [HBs] antigen and/or positive hepatitis core antibody [HBc]), or hepatitis C virus (HCV) antibody or any history of hepatitis from any cause with the exception of hepatitis A. Subjects who are immune to hepatitis B because of vaccination can be included.
4. History of or current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection), including history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
5. Subjects with a history of Varicella zoster virus who experienced any episode or recurrence of Herpes Zoster infection within 1 year of screening must be excluded. (A history of Herpes simplex types 1 and 2 and vaginal candidiasis are permitted.)
6. Pregnant or breast feeding female or subject is intending to become pregnant or breastfeed.
7. Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, = New York Heart Association Classification (NYHA) III/IV) or clinically significant illness in the 3 months prior to initial study drug administration that, in the investigator’s opinion, represents a safety risk for the subject’s participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the subject from safely completing the assessments required by the protocol.
8. Any of the following laboratory findings:
a. White blood cell count <3.0 x 109 cells/L
b. Neutrophil count <1.5 x 109 cells/L
c. Platelet count <100 x 109 cells/L
d. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN)
9. History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
10. Clinically significant abnormalities at the discretion of the investigator detected on vital signs or physical examination (other than atopic dermatitis) at screening or baseline (Day 1 pre-dose).
11. History of eczema herpeticum in the last 12 months prior to screening.
12. Subjects who have had an attenuated vaccination within 4 weeks of baseline or are expected to have one during the course of the study.
13. Participation in another experimental therapy study within 5 times the half-life (if known) or 12 weeks (if not known) of the experimental therapy, prior to baseline, or current enrollment in any other interventional study.
14. Having used any of the following treatments:
a. Exposure to a biologic therapy for atopic dermatitis
b. Immunosuppressive/ immunomodulating drugs (e.g., sys
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: In adult subjects with moderate to severe atopic dermatitis:<br> ? To assess the clinical efficacy of repeated IV doses of MOR106 as assessed by percentage change from baseline in Eczema Area and Severity Index (EASI) score at Day 85 visit.<br> ;Primary end point(s): Percent change in Eczema Area and Severity Index (EASI) score from baseline to Day 85 visit.;Timepoint(s) of evaluation of this end point: Day 85 visit;<br> Secondary Objective: In adult subjects with moderate to severe atopic dermatitis:<br> ? To assess the clinical efficacy of repeated IV doses of MOR106.<br> ? To assess the safety and tolerability of repeated IV doses of MOR106.<br> ? To assess the immunogenicity of repeated IV doses of MOR106.<br> ? To characterize the PK of repeated IV doses of MOR106.<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Various time points throughout the trial as specified in the protocol;<br> Secondary end point(s): ? Proportion of subjects who achieve =50% overall improvement in EASI score from baseline to Day 85 visit and at all timepoints.<br> ? Proportion of subjects who achieve an IGA score of 0 or 1 at Day 85 visit and all timepoints.<br> ? Proportion of subjects who achieve IGA score reduction of =2 at Day 85 visit and all timepoints.<br> ? Percent change in SCORAD score from baseline to Day 85 visit and at all timepoints.<br> ? Incidence of TEAEs, AESIs, SAEs, and discontinuations due to AEs.<br> ? Characterization of the MOR106 immunogenetic profile from baseline through Day197/ED visit.<br> ? Characterization of the MOR106 PK profile from baseline through Day 197/ED visit.<br>